Kura Oncology, Inc.

Ladies and gentlemen, please stand by. Good day and welcome to the Cura Oncology third quarter 2022 earnings conference call. Today's conference is being recorded. Now I would like to turn the conference over to your host, Pete Despain, Senior Vice President of Investor Relations. Please go ahead.

Thank you, Jake. Good morning and welcome to Cura Oncology's third quarter 2022 conference call. Joining me on the call are Dr. Troy Wilson, our President and CEO, and and Tom Doyle, our Senior Vice President of Finance and Accounting. Before I turn the call over to Dr. Wilson, I'd like to remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to Kuro's filings with the SEC, which are available from the SEC or on the Kuro Oncology website, for information concerning risk factors that could affect the company. With that, I'll now turn the call over to Troy.

Thank you, Pete, and thank you all for joining us this morning. Today, we announced a $25 million equity investment from Bristol Myers Squibb priced at $18.25 per share. As part of the transaction, BMS will appoint a member to our Global Steering Committee and provide valuable strategic input into our global development strategy. Notably, we'll maintain full ownership and control of our programs and operations. We have very much appreciated our engagement with and feedback from our BMS colleagues who are leaders in the discovery and development of transformational cancer treatments. This equity investment strengthens the relationship between our organizations, and it provides us with key insights and expertise. We're pleased to have the confidence of the BMS team. We look forward to working with them to deliver innovative science with the potential to benefit patients. This morning we also announced a term loan facility from Hercules Capital, providing loan proceeds of up to $125 million, of which $10 million will be drawn immediately after closing. Hercules has a long history of investing in innovative biotechnology companies, and we are grateful for their support. With the $25 million equity investment from BMS and the $10 million initial draw from the Hercules term loan, We now have $462.8 million in cash pro forma for September 30th, 2022. Furthermore, if the term loan is fully drawn, proceeds from these two transactions together with our existing cash are expected to fund our current operating plan into 2026. These transactions augment our already strong balance sheet and they give us significant flexibility as we prepare to advance into the registration enabling portion of COMET-001 for zift amenib, initiate multiple combination studies for zift amenib in earlier lines of acute myeloid leukemia, and continue to expand and invest in our farnesyl transferase inhibitor programs. We were also proud to announce this morning that our abstract reporting updated data from COMET-001 has been accepted for an oral presentation at the upcoming American Society of Hematology annual meeting in New Orleans. The abstract, which will be published on the ASH website a bit later this morning, highlights the encouraging safety profile and clinical activity of Ziftomenib in patients with relapsed and refractory AML. The abstract includes 30 all-comer AML patients from the Phase Ia dose escalation portion of COMET001 and 24 NPM1 mutant or KMT2A rearranged AML patients from the Phase 1B portion, 12 patients dosed at 200 milligrams, and 12 patients dosed at 600 milligrams. We also enrolled an additional 18 patients in a Phase 1B extension at the 600 milligram dose. Note these patients are not included in the abstract, which was submitted back on August 2nd using an early summer data cutoff. We look forward to sharing a more mature data set, including preliminary data from an additional 18 patients in the Phase 1B extension during our oral presentation at ASH. We'll also be hosting an in-person investor event featuring two of the trial's investigators immediately following the oral session on December 10th. Please stay tuned for more details. Meanwhile, we await feedback from FDA on the recommended Phase 2 dose for Zifta-Medib as well as the protocol for the Phase II registration-directed portion of COMET-001. We also intend to initiate studies of ziftomenib in combination with standards of care in earlier lines of therapy in AML patients. We have designed these Phase I studies to assess the safety, tolerability, and therapeutic activity of ziftomenib in combination with various regimens, including venetoclaxonazacitidine, FLT3 inhibitors, and the combination of 7 plus 3. We're very excited about the potential for these combination studies to further unlock the value of ziftomenib for patients with acute myeloid leukemia. We anticipate initiating the Phase II registration-directed portion of COMET-001 and the first in a series of Phase I combination studies in frontline and relapsed refractory AML in the first half of 2023 pending FDA review of our recommended phase two dose protocols. We continue to have strong conviction in Ziftomenib and its potential to be a best-in-class menin inhibitor. Our confidence is supported by a growing body of clinical data, and we look forward to sharing an update on the program with you at ASHE. Now let's turn our attention to our farnesyl transferase inhibitor programs. We continue to view farnesyl transferase inhibition as a potentially valuable therapeutic and commercial franchise, one with potential to deliver multiple opportunities in oncology. Our initial therapeutic application of tipifarnib, our first-generation FSI as a targeted therapy, was via direct inhibition of the HRAS oncogenic protein. These pioneering efforts ultimately led to a breakthrough therapy designation award in for tibifarnib as a monotherapy in recurrent and metastatic HRS mutant head and neck squamous cell carcinoma. More recently, we've been building upon the encouraging monotherapy activity of tibifarnib with a focus on overcoming drug resistance. Late last year, we initiated the current head and neck study, which was designed to evaluate the combination of tibifarnib and alpelisib, an inhibitor of PI3 kinase alpha, in selected HNSCC patient cohorts. We believe that HRAS and PI3 kinase alpha are codependent oncogenes in HNSCC, and the combination of the two inhibitors has potential to provide improved antitumor activity relative to inhibition of either target alone. The initial cohort of the current head and neck study is comprised of patients with PIK3CA-dependent HNSCC. In August, we announced the first patient dosed in a second cohort comprised of patients with HRAS overexpression. Last week at the EORTC NCI AACR Molecular Targets and Cancer Therapeutics Symposium in Barcelona, we reported the first demonstration that the combination of tipifarnib and alpelisib can induce a durable clinical response in a PIK3CA-dependent HNSCC. A patient with stage 3 squamous cell carcinoma of the tonsil with a PIK3CA mutation and HRS overexpression has achieved a durable partial remission in current HN. The 35-year-old patient enrolled in the study after failing two prior treatments and experienced an 81% reduction in target lesions after just one cycle of tipifarnib and nalpelacib, followed by an 84% reduction after three cycles. The patient continues on study for more than 27 weeks as of last week's presentation. Treatment-related adverse events in current HN have been consistent with the known safety profiles of each drug and are manageable with no dose-limiting toxicities reported to date. Our team is now working to identify a recommended Phase II dose and schedule for the combination with a goal of determining the optimum biologically active dose for the PIK3CA cohort in mid-2023. Meanwhile, we've continued our efforts to demonstrate the potential for tipifarnib to drive durable responses as a monotherapy in recurrent and metastatic HRAS mutant HNSCC through our AIM-HN registration-directed trial. Although we continue to observe evidence of meaningful clinical activity in patients enrolled with AIM-HN, we've elected to close the trial to further enrollment due to significant feasibility challenges. We're currently evaluating the best way to harvest and use the clinical data from RUNHN, which formed the basis of our breakthrough therapy designation, along with the data from AIMHN to inform future development of the program. We'd like to take this opportunity to thank the patients, investigators, and study teams who have participated in the AIMHN study. It's important to note that given the significant overlap between patients with HRAS overexpression and HRAS mutation, HRAS mutant HNSCC patients in the United States may be eligible to enroll in the ongoing current HN study. Beyond HNSCC, we continue to elucidate the roles of FTIs in preventing or delaying the emergence of resistance for certain classes of targeted therapy with potential to drive deeper and more durable responses in large solid tumor indications. One of these emerging combination opportunities was unveiled earlier this year at the American Association for Cancer Research annual meeting. The preclinical data generated through a collaboration with Inserm support the potential of tipifarnib to prevent emergence of resistance to osimertinib and other potent EGFR inhibitors. Motivated by this significant opportunity, we've initiated a phase one study of tipifarnib in combination with osimertinib in EGFR mutant on small cell lung cancer and expect to dose the first patient later this quarter. We intend to perform initial clinical evaluation of tipifarnib and osimertinib to gather valuable experience and data while in parallel advancing KO2806, the lead development candidate in our next generation FTI program through IND-enabling studies. Last week at the triple meeting, our collaborators at NSERM presented a follow-up poster which extended their findings from EGFR to other oncogenic drivers. A copy of the poster is available on the CURA website. Based on these recent findings as well as our own internal translational research efforts, We continue to investigate combinations of FDIs with other potent targeted therapies in preclinical studies. We intend to evaluate KO2806 in several of these combinations, and we remain on track to submit an investigational new drug application for KO2806 later this quarter. With that, I'll now turn the call over to Tom Doyle for a discussion of our financial results.